US-TX, Principal Scientist, Package Development 208892BR-MZ
Principal Scientist, Package Development
Global Drug Development
TECHNICAL R & D GDD
Fort Worth, TX
Research & Development
Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of primary packaging, processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall GDD Packaging/Device strategies and goals.
1. Actively participate in teams, projects, networks and/or platforms. Actively contribute to team goals. Fulfill related tasks and responsibilities related to own discipline and ensure all own activities are aligned with overall drug development process. Provide strategic and scientific contribution to Networks, with target achievements according to network charter and objectives. Interpret results, evaluate data, draw relevant conclusions, and write reports. Contribute to risk analyses and/or peer review and process challenge meetings. Interact/collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and deliveries primary packaging or medical devices.
2. Proactively support generation of international registration documents, including interaction with authorities where appropriate. Generate appropriate scientific documents to hand over to internal and/or external agencies or partners.
3. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Proactively contribute to setting, updating and monitoring of team goals.
4. Translate team goals into daily work. Coach team members and support objectives setting, performance evaluations and development planning discussions where appropriate. Support the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Engage and drive culture change consistent with GDD values and objectives. Consistently demonstrate good change management practices to protect product quality.
5. Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines. Provide quality documentation and assessments in a timely manner.
6. Actively participate in budget forecast, grant preparation and tracking of invoices. Demonstrate cost awareness in all assigned projects and/or networks. Contribute to evaluation of new scientific technologies/equipment and prepare CAR and USR if applicable.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: BS or equivalent in Packaging, Engineering or applicable discipline. Desirable: Advanced degree in a scientific or relevant discipline (M.S. or equivalent).
1. 5+ years of packaging experience in the Pharmaceutical or Medical Device industry developing solutions and leading packaging and/or device programs.
2. Thorough understanding of development processes in primary packaging and medical device development.
3. Ability to work in and/or lead teams.
4. Strong leadership skills.
5. Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
6. Very good communication skills. Good presentation skills and scientific/technical writing skills. Advanced coaching skills.
7. Excellent knowledge of laboratory and/or technical tools. Good knowledge of software and computer tools.
8. Profound literature search skills.
9. May require up to 15% travel.
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